Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of TREDAPTIVE Tablet in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,166
- 主要终点
- Change From Baseline in Total Cholesterol at Week 12
研究概览
简要总结
This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are treated with TREDAPTIVE tablet within current local label for the first time
- •Participants with primary hypercholesterolemia or mixed dyslipidemia
- •Participants who are treated with TREDAPTIVE for more than or equal to 24 weeks will be included in long-term surveillance
- •Special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected.
排除标准
- •Participant who is treated with TREDAPTIVE tablet before contract and out of enrollment period
- •Participant who has a contraindication to TREDAPTIVE tablet according to the current local label
研究组 & 干预措施
All participants
Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
干预措施: Niacin (+) laropiprant (Drug)
结局指标
主要结局
Change From Baseline in Total Cholesterol at Week 12
时间窗: Baseline and Week 12
Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Percentage of Participants With Any Adverse Experience
时间窗: From start of treatment through 14 days after the last dose (Up to 26 weeks)
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Percentage of Participants With Adverse Drug Reactions
时间窗: From start of treatment through 14 days after the last dose (Up to 26 weeks)
An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.
Change From Baseline in Triglycerides at Week 12
时间窗: Baseline and Week 12
Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline and Week 12
Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
时间窗: Baseline and Week 12
Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
Investigator's Overall Efficacy Evaluation at Week 12
时间窗: Baseline and Week 12
The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.
Change From Baseline in Total Cholesterol at Week 24
时间窗: Baseline and Week 24
Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
时间窗: Baseline and Week 24
Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Change From Baseline in Triglycerides at Week 24
时间窗: Baseline and Week 24
Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
Investigator's Overall Efficacy Evaluation at Week 24
时间窗: Baseline and Week 24
The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24
时间窗: Baseline and Week 24
Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE
次要结局
未报告次要终点